The purpose of this study is to determine if pregnancy-limited, short-term combination HIV treatment regimens -- which were used solely for the prevention of mother to child transmission of HIV and discontinued postpartum -- decreases the effectiveness of a standard initial regimen of anti-HIV drugs when subsequent treatment is needed.

The Effect of Prior Short Course Combination Antiretroviral Therapy Administered for the Prevention of Mother-to-Child Transmission (pMTCT) of HIV-1 on Subsequent Treatment Efficacy in Treatment-"Nearly Naive" Participants

Percentage of Participants With Early Virologic Response [ Time Frame: At Week 24 ] [ Designated as safety issue: No ]

Plasma HIV-1 Viral Load Fewer Than 400 Copies/ml

Secondary Outcome Measures:

Time to First Safety Event [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]

Time from starting study treatment to first grade 3 or 4 sign/symptom or laboratory abnormality and at least one grade higher than baseline. Grading used the Division of AIDS (DAIDS) 2004 Severity of Adverse Events Tables.

Percentage of Participants With Early Virologic Suppression [ Time Frame: At Weeks 24 ] [ Designated as safety issue: No ]

Plasma HIV-1 Viral Load Fewer Than 50 Copies/ml

Percentage of Participants With Late Virologic Response [ Time Frame: At Week 48 ] [ Designated as safety issue: No ]

Plasma HIV-1 Viral Load Fewer Than 400 Copies/ml

Time to Initial Virologic Response [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Time from enrollment to scheduled week of first plasma HIV-1 RNA viral load fewer than 400 copies/mL.

Time to Initial Virological Failure [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Virologic failure defined as two consecutive measurements of plasma HIV-1 RNA at least 400 copies/mL at or after the week 16 study visit. Time measured from enrollment.

Time to Loss of Virologic Response by Week 48 (Defined by FDA TLOVR Algorithm) [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Stopping and restarting highly active antiretroviral therapy (HAART) is not generally recommended because it has the potential to allow drug-resistant HIV to emerge. However, to prevent mother-to-child transmission (MTCT), HIV infected women who are pregnant are temporarily put on HAART, even if HIV treatment is not indicated at the time. It is unknown if such short-term therapy affects the viral response to HAART later, when permanent therapy is clinically indicated. The purpose of this study is to determine if HAART taken to prevent MTCT during pregnancy has an effect on the ability of a standard initial regimen of HAART to suppress HIV viral load.

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> Study follow-up will last for 48 weeks per participant. Participants will take a daily regimen of efavirenz and emtricitabine/tenofovir disoproxil fumarate. There will be 8 clinical visits in this study; visits will occur at baseline and at Weeks 2, 4, 8, 16, 24, 36, and 48. At each visit, a physical exam, blood and urine collection, and pregnancy tests will occur. At some visits, adherence, quality-of-life, and birth control interviews will be completed.

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> Enrollment in this study will last until 47 participants have joined or until December 31, 2009, whichever comes later.

Eligibility

Ages Eligible for Study:

16 Years and older

Genders Eligible for Study:

Female

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

HIV-1 infected

Viral load of 500 copies/mL or more

Prior HAART for more than 7 days, but less than 40 weeks during at least one previous pregnancy for prevention of MTCT of HIV

Clinical or laboratory indication to start HAART, in the opinion of the participant's physician

Use of HIV vaccine, chronic systemic corticosteroids, interleukins, interferons, other cytokines, or investigational therapy within 30 days prior to study entry

Acute or chronic therapy for certain serious medical illnesses within 14 days of study entry. Participants who have completed 7 days of therapy and are judged clinically stable are not excluded.

Cancer requiring systemic chemotherapy

Known allergy/sensitivity to the study drugs or their formulations

Current drug or alcohol use that, in the opinion of the investigator, would interfere with the study

Two consecutive HIV viral loads of more than 5,000 copies/mL 8 weeks or more following initiation of HAART during pregnancy and while still receiving HAART

Two consecutive viral loads of more than 400 copies/mL 24 weeks or more following initiation of HAART during pregnancy while still receiving HAART

Current imprisonment or involuntary incarceration in a medical facility for psychiatric or physical illness

Pregnancy or breastfeeding

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00442962